FRONTIER DEVICES NEURO SYSTEM

{0}------------------------------------------------ K100205 ## Section 5 510k Summary : ## DEC 1 3 2010 The following information is provided as required by 21 CFR 807.87 for the 510(k) premarket notification for the plate and screw system, Frontier Devices Neuro Closure System. It has been revised from the original S10k Summary submitted in January 2010 in accordance with FDA requests. | Date Prepared: | November 30, 2010 | | | | | | | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|-------------------------------------------|-----|-------------------------------|-----|------------------| | Sponsor : | Frontier Devices<br>153A Cahaba Valley Parkway<br>Pelham, AL 35124 | | | | | | | | FDA Registration #: | 1065595 | | | | | | | | Contact Person: | Don Petersen, Ph.D.<br>Director Quality Assurance and Regulatory Affairs<br>205-733-0901 (phone)<br>205-733-8445 (fax)<br>dpetersen@frontierdevices.com | | | | | | | | Proprietary Names: | Frontier Devices Neuro Closure System | | | | | | | | Common Names: | Bone plates and screws | | | | | | | | Regulation Number: | 882.5320 | | | | | | | | Classification Name: | Preformed alterable cranioplasty plate | | | | | | | | Product Codes: | <table><tr><td>GWO</td><td>Plate, cranioplasty, preformed, alterable</td></tr><tr><td>HBW</td><td>Fastener, Plate, Cranioplasty</td></tr><tr><td>GXR</td><td>Cover, Burr hole</td></tr></table> | GWO | Plate, cranioplasty, preformed, alterable | HBW | Fastener, Plate, Cranioplasty | GXR | Cover, Burr hole | | GWO | Plate, cranioplasty, preformed, alterable | | | | | | | | HBW | Fastener, Plate, Cranioplasty | | | | | | | | GXR | Cover, Burr hole | | | | | | | | Device Classification: | Class II | | | | | | | | Panel: | Intraocular, Corneal, and Neuromaterials Devices Branch | | | | | | | | Predicate Devices: | Synthes Low Profile Neuro System (K042987)<br>Synthes 2.0 mm Titanium T-Plate (K072758)<br>Synthes Cranial Spring (K974206) | | | | | | | | Device Descriptions: | Frontier Devices Neuro System<br>The Frontier Devices Neuro System consists of titanium bone plates and screws of<br>various shapes and sizes.<br>Plates | | | | | | | | | The plates are made from unalloyed titanium that conforms to the ASTM F67 standard.<br>Plates are 0.4 and 0.6 mm thick and come in a variety of shapes and sizes that are<br>designed for cranial closure applications. The shapes and corresponding sizes include: | | | | | | | | | Straight plates 9-12mm long (1x1, 2x2, 5 and 7 holes)<br>Box plates 10mm x 10mm to 16mm x 16mm (4 hole)<br>X-plate 8mm x 8mm (4 hole)<br>Y-plate 16mm long (6 and 8 holes) | | | | | | | Frontier Devices 510(k) Premarket Notification Submission Neuro Closure System {1}------------------------------------------------ Double Y-plate 18mm to 21mm long (6 and 8 hole) Strut plate 24 and 35mm long (6 and 8 hole) #### Burr Hole Covers The burr hole covers are are made from unalloyed titanium that conforms to the ASTM F67 standard. They are 0.4 and 0.6 mm thick and are circular in shape with equi-spaced drill holes around the circumference. The burr hole covers have two basic shapes. The burr hole cover for shunt has a segment of the circular burr hole cover missing which is where a shunt device is placed. The other burr hole cover is a complete circle. The corresponding sizes include: Burr hole covers Burr hole covers for shunt 12mm to 24mm diameter 12mm to 24mm diameter #### Mesh The mesh is made from unalloyed titanium that conforms to ASTM F67 standard. They are 0.4 and 0.6mm thick and rectangular in shape, 90mm x 120mm. #### Screws The screws are self-drilling screws that do not require a pre-drilled pilot hole and are made from a titanium alloy, Ti-6Al-4V, that conforms to the ASTM F136 standard. Screws are 1.5 to 1.8 mm in diameter and range in length from 3 to 6 mm. Intended Use: Technology #### Frontier Devices Neuro System Frontier Devices Neuro System is intended for use in selective trauma of the cranial skeleton and cranial surgery. The plates and screws of the Frontier Devices Neuro Closure System have similar dimensions, designs and materials as the predicate devices. The plates Characteristics are 0.4 and 0.6 mm thick, made from unalloyed titanium (ASTM F67) and have similar design shapes and sizes as the predicate devices. The screws are all made from titanium alloy (ASTM F136) with diameters of 1.5 mm and 1.8 mm and lengths of 3-6 mm which are similar to the predicate devices. Performance Tests Screw insertion tests on representative screws showed them to have similar results as predicate screws. In addition, LAL endotoxin testing was done on screws, plates and mesh devices and all the devices had endotoxin levels of less than 0.06 EU/ml. Substantial Equivalence The Frontier Devices Neuro Closure System consists of plates and screws that are similar in material composition and have the same indications for use as the predicate device. All of the technical characteristics are substantially equivalent to the corresponding characteristics of the predicate devices. There may be slight differences in dimensions and shapes between the Frontier Devices Neuro Closure System and the predicate devices, however, the information provided in this submission proves substantial equivalence to the predicate devices. Frontier Devices 510(k) Premarket Notification Submission Neuro Closure System Page 5-2 {2}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002 Don Peterson, Ph.D. Directory Quality Assurance and Regulatory Affairs Folsom Metal Products, Incorporated 153 Cahaba Valley Parkway Pelham, Alabama 35124 DEC 1 3 2010 Re: K100205 Trade/Device Name: Frontier Devices Neuro Closure System Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: II Product Code: GWO, HBW, GXR Dated: November 30, 2010 Received: December 2, 2010 Dear Dr. Peterson: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {3}------------------------------------------------ ### Page 2- Dr. Peterson Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), . please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Smaronne Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use K100205 510(k) Number (if known): 100205 DEC 1 3 2010 Device Name: Frontier Devices Neuro Closure System Indications For Use: The Frontier Devices Neuro System is intended for use in selective trauma of the cranial skeleton and cranial surgery. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluati (Division Sign-Off) (Division of Anesthesiology, General Massial Infection Control, Dental Devices 510(k) Number: Frontier Devices K100205 - Response Letter #2 - 7-8-10 Appendix E Page E-2